drugset / Press release

Evolus Announces Health Canada Acceptance For Review Of The New Drug Submission For PrabotulinumtoxinA

2017-10-26 · Evolus, Inc. · original evolus.com ↗

SANTA BARBARA, Calif., Oct. 26, 2017 /PRNewswire/ -- Evolus, Inc. ( www.Evolus.com ) received confirmation from Health Canada that the New Drug Submission (NDS) for prabotulinumtoxinA, a 900 kilodalton (kDa) Botulinum toxin Type A, for the treatment of adult patients with glabellar lines, also known as "frown lines" between the eyebrows, has been accepted for review. The NDS application is supported by the results of a Phase III randomized, multi-center, active and placebo-controlled, double blind, single dose trial (EVB-003). Rui Avelar, M.D., Chief Medical Officer of Evolus, said, "The NDS acceptance for review is a significant milestone achievement for the prabotulinumtoxinA development program. We look forward to working with Health Canada during the agency's review of the application." About PrabotulinumtoxinA PrabotulinumtoxinA is a 900 kDa purified botulinum toxin type A complex. The product candidate's Biologics License Application is currently under review by the U.S. Food and Drug Administration. The product candidate's Marketing Authorization Application is currently under review by the European Medicines Agency. About Evolus, Inc. Evolus, Inc. is a medical aesthetics company focused on providing physicians and their patients with expanded choices in aesthetic procedures and treatments. Evolus, Inc. focuses on the self-pay aesthetic market and its lead product candidate is an injectable 900 kDa purified botulinum toxin type A complex. Evolus Press Contacts: September Riharb, Vice President, Marketing Tel: +1-805-764-6300 Email: [email protected] Jeff Plumer, Vice President, Legal Tel: +1-949-284-4555 Email: [email protected] SOURCE Evolus, Inc. View All News

The release as fetched from its publisher. evolus.com ↗